Evidence map›Paper›PMID 37080617›Full record

ArticleBMJ open2023

Mixed-methods feasibility study to inform a randomised controlled trial of proton pump inhibitors to reduce strictures following neonatal surgery for oesophageal atresia.

Tracy Karen Mitchell, Nigel J Hall, Iain Yardley, Christina Cole, Pollyanna Hardy, Andy King, David Murray, Elizabeth Nuthall, Charles Roehr, Kayleigh Stanbury and 3 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.3field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Tracy Karen MitchellDepartment of Public Health, Policy and Systems, Faculty of Health and Life Sciences, Institute of Population Health, University of Liverpool, Liverpool, UK Tracy.Mitchell@Liverpool.ac.uk.ORCID 0000-0003-0014-8016
Nigel J HallUniversity Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK.ORCID 0000-0001-8570-9374
Iain YardleyEvelina Children's Hospital, Guy's & St. Thomas's NHS Foundation Trust, London, UK.ORCID 0000-0002-6928-2267
Christina ColeNational Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0002-8798-2136
Pollyanna HardyNational Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0003-2937-8368
Andy KingNational Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0001-5180-7179
David MurrayNational Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0001-9010-2905
Elizabeth NuthallNational Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0002-5092-7643
Charles RoehrNational Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0001-7965-4637
Kayleigh StanburyNational Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0002-8726-2411
Rachel WilliamsNational Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0002-5872-1690
John PearceTOFS, Nottingham, UK.
Kerry WoolfallDepartment of Public Health, Policy and Systems, Faculty of Health and Life Sciences, Institute of Population Health, University of Liverpool, Liverpool, UK.ORCID 0000-0002-5726-5304
University of Oxford · GBUniversity of Liverpool · GBKing's College London · GBUniversity of Southampton · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis mixed-methods feasibility study aimed to explore parents' and medical practitioners' views on the acceptability and design of a clinical trial to determine whether routine prophylactic proton pump inhibitors (PPI) reduce the incidence of anastomotic stricture in infants with oesophageal atresia (OA).

designSemi-structured interviews with UK parents of an infant with OA and an online survey, telephone interviews and focus groups with clinicians. Data were analysed using reflexive thematic analysis and descriptive statistics. PARTICIPANTS AND

settingWe interviewed 18 parents of infants with OA. Fifty-one clinicians (49 surgeons, 2 neonatologists) from 20/25 (80%) units involved in OA repair completed an online survey and 10 took part in 1 of 2 focus groups. Interviews were conducted with two clinicians whose survey responses indicated they had concerns about the trial. OUTCOME MEASURES: Parents and clinicians ranked the same top four outcomes ('Severity of anastomotic stricture', 'Incidence of anastomotic stricture', 'Need for treatment of reflux' and 'Presence of symptoms of reflux') as important to measure for the proposed trial.

resultsAll parents and most clinicians found the use, dose and duration of omeprazole as the intervention medication, and the placebo control, as acceptable. Parents stated they would hypothetically consent to their child's participation in the trial. Concerns of a few parents and clinicians about infants suffering with symptomatic reflux, and the impact of this for study retention, appeared to be alleviated through the symptomatic reflux treatment pathway. Hesitant clinician views appeared to change through discussion of parental support for the study and by highlighting existing research that questions current practice of PPI treatment.

conclusionsOur findings indicate that parents and most clinicians view the proposed Treating Oesophageal Atresia with prophylactic proton pump inhibitors to prevent STricture (TOAST) trial to be feasible and acceptable so long as infants can be given PPI if clinicians deem it clinically necessary. This insight into parent and clinician views and concerns will inform pilot phase trial monitoring, staff training and the development of the trial protocol.

Indexed as

Esophageal AtresiaEsophageal StenosisOmeprazoleProton Pump InhibitorsRandomized Controlled Trials as TopicAdultAttitude of Health PersonnelChemopreventionConstriction, PathologicFeasibility StudiesGastroesophageal RefluxHealth Care SurveysHumansInfant, NewbornParentsPatient Acceptance of Health CareOmeprazoleProton Pump Inhibitorsneonatal intensive & critical careneonatologypaediatric gastroenterologyqualitative researchstatistics & research methods

Identifiers

PMID37080617
PMCPMC10124212
OpenAlexW4366598133

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.